{"doc_desc":{"title":"Cohorte de nouveaux-n\u00e9s atteints d'asthme\/mesure du NO expir\u00e9","idno":"FRESH-PEF60195-fr","producers":[{"name":"Jocelyne JUST","affiliation":"SORBONNE UNIVERSITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60195-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60195"},{"agency":"FReSH","code":"FRESH-PEF60195"}]},"title":"Cohorte de nouveaux-n\u00e9s atteints d'asthme\/mesure du NO expir\u00e9","alternate_title":"NOA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Jocelyne;JUST","PILabo":"CENTRE DE L'ASTHME ET DES ALLERGIES EA 4064 SANT\u00c9 PUBLIQUE ET ENVIRONNEMENT APHP, UNIVERSIT\u00c9 PARIS 6","affiliationName":"SORBONNE UNIVERSITE","extlink":[{"title":"ORCID","uri":"0000-0002-5646-2429","role":"pi id"},{"title":"IdRef","uri":"09336881X","role":"pi id"},{"title":"SIREN","uri":"130023385","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jocelyne.just@ahparis.org","isContact":"Oui"},{"type":"investigator","name":"Isabelle;MOMAS","PILabo":"EA 4064 SANT\u00c9 PUBLIQUE ET ENVIRONNEMENT UNIVERSIT\u00c9 PARIS 5","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0003-4344-3787","role":"pi id"},{"title":"IdRef","uri":"059579331","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.momas@u-paris.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE DE PNEUMOLOGIE DE LANGUE FRANCAISE","extlink":[{"title":"SIREN","uri":"310133608"}]},{"name":"","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Jocelyne;JUST","email":"jocelyne.just@ahparis.org","type":"contact","affiliationName":"SORBONNE UNIVERSITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02en5vm52","role":"organisation id","title":"ROR"},{"uri":"130023385","role":"organisation id","title":"SIREN"}]},{"name":"Isabelle;MOMAS","email":"isabelle.momas@u-paris.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"p\u00e9diatriques"},{"keyword":"morbidit\u00e9"},{"keyword":"mortalit\u00e9"},{"keyword":"pronostic"},{"keyword":"facteurs g\u00e9n\u00e9tiques"},{"keyword":"diagnostic"}],"topics":[{"topic":"Allergologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/af65e2bf-afc5-45e8-a0fc-364dfb48f0a4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Asthme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1656445230","title":"CIM-11"}]}],"purpose":"Montrer que l\u2019\u00e9l\u00e9vation du NO, biomarqueur de l\u2019inflammation bronchique, est un facteur de risque attendu de persistance du nourrisson siffleur r\u00e9curent vers l\u2019asthme de l\u2019enfant d\u2019\u00e2ge pr\u00e9scolaire (\u00e2g\u00e9 de 4 \u00e0 7 ans). Objectifs secondaires : - R\u00e9aliser l\u2019assemblage d\u2019une cohorte internationale de patients s\u00e9lectionn\u00e9s sur des crit\u00e8res homog\u00e8nes \u00e9tablis par un comit\u00e9 d\u2019experts. - Permettre un recueil homog\u00e8ne en temps r\u00e9el de donn\u00e9es r\u00e9trospectives et prospectives sur la MB de l\u2019enfant, gr\u00e2ce \u00e0 la cr\u00e9ation d\u2019une base de donn\u00e9es en ligne. - Servir de support d\u2019\u00e9tudes g\u00e9n\u00e9tiques et une collection d\u2019ADN est effectu\u00e9e en parall\u00e8le.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" enfant inf\u00e9rieur \u00e0 30 mois - asthme ou rhinite allergique\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['- Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques - Gestion des donn\u00e9es manquantes par retour au dossier source - Relance des sujets pour r\u00e9aliser les visites de suivi - Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"315"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"Utilisation impossible des donn\u00e9es par des \u00e9quipes acad\u00e9miques ou des industriels","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"11-08-2014","isContributorPI":"Non","contributorName":"Jocelyne JUST","contributorAffiliation":"SORBONNE UNIVERSITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Industrie","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Entretiens : saisie manuelle \u00e0 partir d\u2019un questionnaire papier Examens biologiques : saisie manuscrite","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Paris et r\u00e9gion parisienne"},"dataTypes":{"clinicalDataDetails":"Informations recueillies lors de l'examen clinique : Signes muco-cutan\u00e9s, oculaires, neurologiques , vasculaires.","biologicalDataDetails":"ADN, cellules","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}